A Pharmacokinetic and Safety study comparing Fluticasone Propionate and Albuterol Sulfate to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Children Aged 4 to 11 Years Old

Study Title
An Open Label, Single Dose, 3-Period, Crossover Study to Determine the Pharmacokinetic Profile and Safety of Fluticasone Propionate/Albuterol Sulfate (Fp/ABS) Multidose Dry Powder Inhaler with e-Module (eMDPI) Compared to Fluticasone Propionate Multidose Dry Powder Inhaler (Fp MDPI) in Participants with Asthma (4 to 11 Years Old)
Teva Identifier
TV56248-RES-10204
ClinicalTrials.gov Identifier
NCT06290102
Study Status
Recruiting
Trial Condition(s)
Respiratory
Interventions
Drug: TEV-56248

Study Description

The primary objectives of this study are to determine the pharmacokinetic (PK) profile of fluticasone propionate (Fp) and albuterol sulfate (ABS), delivered in combination, from a single dose of TEV-56248 in participants with asthma, to compare the PK profiles of Fp for different dose strengths of TEV-56248 to that of fluticasone propionate multidose dry powder inhaler (Fp MDPI), and to compare the PK profiles of ABS between the 2 different strengths of TEV-56248.
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Key Participation Requirements

Gender
Female, Male
Age Range
4 Years to 11 Years
Trial Duration
May 07, 2024 - November 25, 2024
Phase
Phase 1

Study Type

Interventional